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Tixel Handpiece THLM0002

by Novoxel Ltd

Tixel Handpiece THLM0002 is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Novoxel Ltd, cleared under FDA 510(k) K202988 on 25 Feb 2021 and listed in FDA GUDID since 24 Oct 2021 (UDI-DI 07290117524015), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K202988

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290117524015 UDI-DI Date24 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202988 Date25 Feb 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202988 decided 25 Feb 2021 Active
  • FDA GUDID UDI-DI 07290117524015 listed 24 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202988
  2. Listed FDA GUDID 07290117524015

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tixel Handpiece
Generic name
Thermo-mechanical skin surface treatment system handpiece
Model / Ref / Catalog
THLM0002
Primary DI / UDI-DI
07290117524015
510(k) Number
FDA product code
GEI
GMDN term
Thermo-mechanical skin surface treatment system handpiece
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Thermo-mechanical skin surface treatment system handpiece

Cleared under the same submission (K202988)

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from Novoxel Ltd

See all devices from Novoxel Ltd →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)